Qc Executive

We are looking for a Quality Control (QC) Analyst with hands-on experience in HPLC (High-Performance Liquid Chromatography). The candidate will be responsible for conducting analytical testing of raw materials, in-process samples, and finished products to ensure compliance with regulatory and quality standards.

Key Responsibilities:

Analytical Testing & Instrument Handling:

• Perform HPLC analysis of raw materials, intermediates, and finished products as per pharmacopoeia and in-house specifications.
• Operate, calibrate, and troubleshoot HPLC instruments (Agilent, Waters, Shimadzu, etc.).
• Conduct other analytical techniques such as UV Spectroscopy, Dissolution, FTIR, and GC (if required).
• Maintain proper documentation (test reports, logbooks, and data sheets) as per GMP.

Quality & Compliance:

• Ensure all activities comply with Good Laboratory Practices (GLP), GMP, and regulatory guidelines.
• Conduct method validation, verification, and transfer for HPLC analysis.
• Support OOS (Out of Specification) investigations, deviations, and CAPAs.
• Participate in internal and external audits (USFDA, WHO, MHRA, etc.).

Process Improvement & Documentation:

• Prepare and review SOPs, analytical protocols, and reports.
• Maintain records in compliance with Data Integrity (ALCOA+ principles).
• Work on troubleshooting and optimization of analytical methods for efficiency.

Key Requirements:

Education & Experience:

• B.Sc / M.Sc / B.Pharm / M.Pharm in Chemistry, Pharmaceuticals, or a related field.
• 2 to 6 years of hands-on experience in HPLC analysis within a pharmaceutical or analytical lab setting.

Skills & Competencies:

• Expertise in HPLC operation, calibration, and troubleshooting.
• Strong understanding of ICH guidelines, USP/EP/JP pharmacopoeial methods.
• Experience in handling regulatory documentation and audits.
• Knowledge of other analytical instruments (GC, UV, FTIR, etc.) is a plus.
• Strong analytical and problem-solving skills. Roles